scholarly journals Multiple Sclerosis Clinical Trials: Part 1—Basic Considerations

2001 ◽  
Vol 3 (1) ◽  
pp. 6-12
Author(s):  
Robert M. Herndon
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Positive Result ◽  
Signs And Symptoms ◽  
Relapsing Remitting ◽  
Varied Distribution

ABSTRACT Clinical trials in neurology are difficult, complex, usually expensive, and fraught with pitfalls. Clinical trials in multiple sclerosis (MS) are particularly difficult because of the relapsing-remitting nature of the disease, the highly varied distribution of the lesions, and varied signs and symptoms. While the number and quality of MS clinical trials have increased enormously in recent years, they remain controversial and are subject to endless criticism. There is no shortage of individuals willing and eager to criticize clinical trials if they claim a positive result. Conversely, negative trials are rarely published1 and, when they are, they are rarely criticized even though some negative trials are equally deserving of criticism. No trial is perfect, and few scientific endeavors are subject to more rigorous review and criticism than clinical trials. This article—the first in a series—will discuss various aspects of planning, designing, and implementing a clinical trial. (Int J MS Care. 2001; 3(1): 6–12)

Digital Technology in Clinical Trials for Multiple Sclerosis: a systematic review. (Preprint)

2020 ◽  
Author(s):  
Marcello De Angelis ◽  
Luigi Lavorgna ◽  
Antonio Carotenuto ◽  
Martina Petruzzo ◽  
Roberta Lanzillo ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Outcome Measures ◽  
Digital Technology ◽  
Clinical Trial Design ◽  
Motor Rehabilitation ◽  
Robot Assisted ◽  
Future Directions ◽  
Treatment Side Effects

BACKGROUND Clinical trials in multiple sclerosis (MS) have leveraged the use of digital technology to overcome limitations in treatment and disease monitoring. OBJECTIVE To review the use of digital technology in concluded and ongoing MS clinical trials. METHODS In March 2020, we searched for “multiple sclerosis” and “trial” on pubmed.gov and clinicaltrials.gov using “app”, “digital”, “electronic”, “internet” and “mobile” as additional search words, separately. Overall, we included thirty-five studies. RESULTS Digital technology is part of clinical trial interventions to deliver psychotherapy and motor rehabilitation, with exergames, e-training, and robot-assisted exercises. Also, digital technology has become increasingly used to standardise previously existing outcome measures, with automatic acquisitions, reduced inconsistencies, and improved detection of symptoms. Some trials have been developing new patient-centred outcome measures for the detection of symptoms and of treatment side effects and adherence. CONCLUSIONS We will discuss how digital technology has been changing MS clinical trial design, and possible future directions for MS and neurology research.

scholarly journals Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhuoran Kuang ◽  
◽  
Xiaoyan Li ◽  
Jianxiong Cai ◽  
Yaolong Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Secondary Outcome ◽  
Specific Information ◽  
Clinical Trial Registry ◽  
Data Set ◽  
Diagnosis Criteria

Abstract Objective To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes. Results A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s). Conclusion Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data.

scholarly journals A comparative study of teriflunomide and dimethyl fumarate within the Swedish MS Registry

2021 ◽  
pp. 135245852110196
Author(s):  
Jan Hillert ◽  
Jon A Tsai ◽  
Mona Nouhi ◽  
Anna Glaser ◽  
Tim Spelman
Keyword(s):  
Multiple Sclerosis ◽  
Real World ◽  
Clinical Effectiveness ◽  
Dimethyl Fumarate ◽  
Population Based ◽  
Life Outcomes ◽  
Treatment Persistence ◽  
Relapsing Remitting ◽  
Relapsing Remitting Multiple Sclerosis

Background: Teriflunomide and dimethyl fumarate (DMF) are first-line disease-modifying treatments for multiple sclerosis with similar labels that are used in comparable populations. Objectives: The objective of this study was to compare the effectiveness and persistence of teriflunomide and DMF in a Swedish real-world setting. Methods: All relapsing-remitting multiple sclerosis (RRMS) patients in the Swedish MS registry initiating teriflunomide or DMF were included in the analysis. The primary endpoint was treatment persistence. Propensity score matching was used to adjust comparisons for baseline confounders. Results: A total of 353 teriflunomide patients were successfully matched to 353 DMF. There was no difference in the rate of overall treatment discontinuation by treatment group across the entire observation period (hazard ratio (HR) = 1.12; 95% confidence interval (CI) = 0.91–1.39; p = 0.277; reference = teriflunomide). Annualised relapse rate (ARR) was comparable ( p = 0.237) between DMF (0.07; 95% CI = 0.05–0.10) and teriflunomide (0.09; 95% CI = 0.07–0.12). There was no difference in time to first on-treatment relapse (HR = 0.78; 95% CI = 0.50–1.21), disability progression (HR = 0.55; 95% CI = 0.27–1.12) or confirmed improvement (HR = 1.17; 95% CI = 0.57–2.36). Conclusion: This population-based real-world study reports similarities in treatment persistence, clinical effectiveness and quality of life outcomes between teriflunomide and dimethyl fumarate.

Effects of BG-12 (dimethyl fumarate) on health-related quality of life in patients with relapsing–remitting multiple sclerosis: findings from the CONFIRM study

2013 ◽  
Vol 20 (2) ◽  
pp. 253-257 ◽  
Author(s):  
Mariko Kita ◽  
Robert J Fox ◽  
J Theodore Phillips ◽  
Michael Hutchinson ◽  
Eva Havrdova ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Short Form ◽  
Dimethyl Fumarate ◽  
Phase Iii ◽  
Health Related Quality ◽  
Relapsing Remitting ◽  
Related Quality ◽  
Health Related

Multiple sclerosis (MS) has a significant impact on health-related quality of life (HRQoL) with symptoms adversely affecting many aspects of everyday living. BG-12 (dimethyl fumarate) demonstrated significant efficacy in the phase III studies DEFINE and CONFIRM in patients with relapsing–remitting MS. In CONFIRM, HRQoL was worse in patients with greater disability at baseline, and who relapsed during the study, and improved with BG-12 treatment. Mean Short Form-36 Physical Component Summary scores for BG-12 increased over 2 years and scores for placebo decreased. Coupled with clinical and neuroradiological benefits, these HRQoL results further support BG-12 as an effective oral treatment for relapsing MS.

scholarly journals Hypothyroidism with special reference to kaphavruta udana vayu – an overview study.

2020 ◽  
Vol 8 (03) ◽  
Author(s):  
Pragati Dwivedi
Keyword(s):  
Clinical Trials ◽  
Differential Diagnosis ◽  
Positive Result ◽  
Special Reference ◽  
Prevalence Rate ◽  
Signs And Symptoms ◽  
Autoimmune Disorder ◽  
Modern Medicine ◽  
Clinical Correlation ◽  
Health Issues

Hypothyroidism is one of the fastest rising health issues in India, with the prevalence rate of 10.95% ~1 in 10 adults. Thus, it is of great need to deal with this ever-emerging disease. In Ayurveda, Hypothyroidism is often taken as Rasa - pradoshaja vyadhi and treated accordingly but the outcome is not as expected always. So, there is a need to find out other conditions which shows similar signs and symptoms as hypothyroidism and that can be considered in differential diagnosis. In Modern medicine the causes of Hypothyroidism are differentiated in deficiency, insufficiency of hormone, inefficiency of gland, autoimmune disorder, Cancer etc. In our study we will refer it with Kaphavruta udana vayu vikriti with the help of classical textual references which will be helpful in the treatment precisely. Aims & objective – 1. To evaluate co-relation between hypothyroidism with kaphavruta udana vayu vikruti 2. To evaluate action of erand sneh in kaphavruta udana vayu vikruti Methodology – All classical texts were referred like Bruhtrayi & Laghutrayi and others to evaluate the clinical correlation of hypothyroidism and kaphavruta udana vayu vikruti. Whether line of treatment mentioned in kaphavruta udana vayu vikruti shows the positive result in hypothyroidism. Conclusion –It was observed that the signs and symptoms of hypothyroidism were very much similar with kapha vruta udana vayu vikruti. Hypothyroidism can successes fully be referred as Kaphavruta udana yavu vikruti. According to textual references we can utilize Eranda Sneha Nasya & Paan in the management of hypothyroidism. Thus, it has significant role in reducing the signs and Symptoms of Hypothyroidism because of its Vata - kaphhara, srotovishodhan, Anulomana, vrushya actions. Further studies and clinical trials are essential to evaluate the efficacy of erand sneha and correlation between hypothyroidism & kaphavruta udana vayu vikriti.

scholarly journals The appearance and increase in the quantity and proportion of the clinical research coordinator's service fee in drug clinical trial research fund and its impact on trial quality

2020 ◽  
Author(s):  
Liran Chen ◽  
Zhimin Chen ◽  
Huafang Chen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Structural Changes ◽  
Continuous Increase ◽  
Clinical Trial Research ◽  
Clinical Research Coordinator ◽  
Research Coordinator ◽  
Drug Clinical Trial

Abstract Objective: The changes of absolute value and relative value of clinical research coordinator service fee and its influence on the quality of drug clinical trial were analyzed.Methods: This study compared the amount and structural changes of drug clinical trial costs in before 3 years and after 3 years of self-examination and inspection initiated by the China Food and Drug Administration, identified the increase number and composition of each individual cost of a clinical trial research funds which including clinical research coordinator service fee, investigator labor fee, subjects examination fee, subjects traffic subsidy, documents management fee, drug management fee, etc.Result: The most significant appearance and increase in volume and proportion were the clinical research coordinator service fee. From the initial few to the global multicenter tumor drug clinical trials RMB31,624 or 34.92% of the proportion and domestic multicenter tumor drug clinical trials RMB16,500,accounted for 33.74%.Discussion: It has become common for more money to be spent on clinical trials to be accompanied by improved quality, but the occurrence and continuous increase of clinical research coordinator service fee were divided into two aspects, On the one hand, the quality of clinical trials was promoted by the large amount of low-skill trivial work undertaken by clinical research coordinator; on the other hand, the quality of clinical trials was undermined by the fact that clinical research coordinator did too much treatment evaluation work that should have been done by the investigator.

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